/ EUROPEAN COMMISSION
DIRECTORATE-GENERAL
ENVIRONMENT
Directorate A – Green Economy
ENV.A.3 - Chemicals

CA-Nov14-Doc.7.2

58th meeting of representatives of Members States Competent Authorities for the implementation of Regulation 528/2012 concerning the making available on the market and use of biocidal products

Report on the fees payable to Members States Competent Authorities pursuant to Article 80(2) of the Biocidal Product Regulation

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 2 299 11 11

E-mail:

ABBREVIATIONS

MS: member states

ECHA: European chemicals agency

BPR: Biocidal product regulation

BP: Biocidal product

CA: Competent authorities

PT: Product type

AS: Active substance

SME: Small and medium-sized enterprise

1. Introduction

1.1. Contextual and legislative background

Regulation (EU) No 528/2012 of 22 May 2012 concerning the making available on the market and use of biocidal products (hereafter the Biocidal Product Regulation- BPR) requires active substances present in biocidal products to be approved at Union level and subsequently authorised as a biocidal productat Union or Member State (MS) level before being made available on themarket.

Besides provisions on fees payable to the European Chemicals Agency (ECHA), which are detailed in Commission Implementing Regulation (EU) No 564/2013 of 18 June 2013, Article 80(2) of the BPR requires each MS to set fee structures and relative amounts payable to their Competent Authorities (CA) for the evaluation and authorisation procedures of active substances (AS) and biocidal products (BP)for which they could be evaluatingCA under the BPR.

MS are indeed entitled to directly charge applicants fees for the evaluation of applications. Accordingly, MSs are expected to establish how these fees will be organised in detail (amount, timing and sequenceof payment, options for refund etc).

In this context, diverging approachesbetween MSs in the structure and amount of fees payable to their CAmay be expected. In view of this, and based on Article 80(2) and on the principles of Article 80(3) of the BPR, the European Commission (COM) has issued a guidance document containing recommendations for MS' fee structures and related procedures with a view to harmonising the latter (cf.CA-Dec12-Doc.5.1.b - Final) and avoiding gaps in national methods and/or fee levels.

1.2. Objectives of the report

The objective of this reportis first to review the implementation of Article80(2) of the BPR based on the fee-related legislative provisions currently in force in MS. The report thus provides an overview of MS' efforts to respect and put BPR provisions into practice, notably as regards the annual fee for the future self-financing of CA and the measures supporting Small and Medium-Sized Enterprises (SMEs). The underlying goal is also to determine to what extent MSs followed recommendations provided in the guidance document mentioned above (CA-Dec12-Doc.5.1.b - Final), in particular with regard to the proposed fee structure. In this respect, input from CAwas highly helpful.

Secondly, the aim is to draw a comparative analysis of the relative costs of AS evaluation, BP authorisation,BP mutual recognitionand annual feein the EU MS, EEA countries and Switzerland for specific typical cases (defined in section 1.4).This is done by analysing therespective procedures and fee structuresestablished in each of the respondent countries, and by highlighting potential divergences and similarities.

1.3 Areas of focus

The four following regulatory procedures required for the making available on the market of a BP have been singled out to compare the overall fee structures and levels in the EUMS, EEA countries and Switzerland:

  • Fees for the evaluation of AS per Product Type (PT) and per additional PT;
  • Fees for the authorisation of a BP and of a BP family;
  • Fees for the mutual recognition of an authorisationfor a BP and for a BP family;
  • The annual fee (optional);
  • Existing measures supportingSMEs in this process.

1.4 Method and limits of analysis

For the purpose of this report, the following typical caseswere taken into account:

  • For active substance approval: a chemical AS for one PT (information on the fee per additional PT is also provided);
  • For biocidal product authorisation: a BP containing a single chemicalAS for a single PT(information on the fee per BP family is also provided);
  • For mutual recognition: a BP containing a single chemicalAS for a single PT (information on the fee per BP family is also provided).

In addition to these typical cases, two qualitative features were considered:

  • The potential annual fee paid by a single company to register a single BP or a BP family and/or to financially support the activities of MS' CA.
  • The potential measures chosen by MSs to support SMEs in this process, i.e. mostly payment facilities and reduced fees.

This approach is used in order to highlight average indicative fee amounts. This means that these amounts do not include any top-up fee that a wide majority of MSs apply to their basic fee (see section 2.1). Thus, figures for AS approval, BP authorisation and mutual recognitionare likely to be significantly higher. Depending on each individual case at hand, a scenario with a minimum and maximum fee to be paid could be drawn.

Moreover, specific procedures such as modification or renewal of authorisations, etc.are excluded from the analysis.

Finally, in some MS, complete and updated data was not always available where the relevant legislationwas currently under review.

2. comparative evaluation of legislative framework and organisational fee structure in eu member states, eea countries and Switzerland

This section aims at comparing the approach used by MSs to set general fee levels, potentially an annual fee, and specific measures to support their SMEs in this context.

2.1. General organisation of fee structure and payment in MSs

Evidently, MSs' organisational structures for BP fee levy do not always strictly follow the options of the guidance document ina clear-cut way. On the contrary, MSs' method and organisation entail many subtleties, as well as specific measures linked to their budgetary and organisational specificities. Therefore, several MSs use a mix of different options to organise their fee structure and levels.

This is summarised in the table below.

Respondents / Option A / Option B / Option C / Option D / Legislation in process of adoption / Legislation currently under review
Member States+ EEA countries and CH / EE, FI, CH / EE, NL, UK, IS / BE, DK, GR, IE, FR, HR, IT, LV, LU, HU, MT, SI, AT, NO, SE, NL, PL, ES, SK, PT, LT, DE / UK , FI / BG, EE, GR, IT, AT, LU, HU, RO, ES / NL, PL, UK, CZ, PT

2.1.1 A large majority of MSs opted for a flat fee with top-up and additionalfees (option C) (=22/28)

Following the table above, it appears that a large majority of MSs(22= BE, DK, GR, IE, FR, HR, IT, LV, LU, HU, MT, SI, AT, NO, SE, NL, PL, ES, SK, PT, LT, DE) have chosen to follow option C of the guidance document (CA-Dec12-Doc.5.1.b –Final). This group thus established a flat fee which applies to all applicants and represents the average costs of assessing a specific type of application. In most of these MS,top-up fees are added to this flat fee.

2.1.2 A minority of MSs opted for a proportionate fee (options A, B and D) (=6/28)

Only 6MSs (EE, FI, CH, NL, UK, IS) chose option A (EE, FI, CH), option B (EE, NL, UK, IS), or option D (UK, FI) of the guidance document- or a mix of both, illustrated un the table above-, which implies collecting a fee at the start of the procedure to which top-feesfees and potential additional fees can be added before the end of the procedure. A maximum fee is also often established.

UK and FI stand out as having set the most tailored approach reflecting the administrative burden of evaluating applications. This implies collecting different fees, for different purposes and at different times during the procedure (option D)- in both cases with hourly/daily work rates.

Furthermore, it is relevant to point out that in two of the MSs who have chosen option A or D, a refund system is in place when the fee paid exceeds the final costs of handling specific applications (EE, UK). Two other countries have also ensured such a possibility (NL, IS). This corresponds to option B of the guidance document.

2.1.3 A large group of MSs are in the process of adoption/review of relevant legislation (14/28)

In 9MSs (BG, EE, GR, IT, AT, LU, HU, RO, ES), the national legislation implementing the BPR as regards fee levy for BPs was still in process of adoption at the time of study. However, the scheme for this purpose had been already defined in most of these MSs .

Moreover, 5MSs are in the process of reviewing their current legislation (NL, PL, UK, CZ, PT).

2.2. Annual fee

As regards the establishment of an annual fee for the registration of authorised BPs, only 9MSs (BE, IE,IT, AT, SK, NO, NL, SE, UK) had set such a fee at the moment of writing; whilst 20 of the respondents had not.Except for NL and SE, most of the existing annual fees are in a 100-500€ range.

The annual fee was suggested in the BPR as a source of revenue to finance overhead expenses under CA' BPR-related activities with a longer-term view of self-financing MSs ' BP fee system, on the same model as the fees payable to the ECHA.

The MSs who have established an annual fee are listed in the table below.

Member States / Nature and purpose of annual fee
BE / The Belgian annual fee is payable to the "Fonds budgétaire des matières premières et des produits" for all AS or BP who received notification, approval of notification, authorisation or mutual recognition.The amount is then calculated based on the quantity of BP placed on the Belgian market (expressed in kg,l or %) and the number of hazard-based points corresponding to each BP.
The annual fee compensates for the human resources costs of internal evaluation for BP. However, such costs are already taken into account and are reflected in the flat fee for AS evaluation.
IE / The Irish annual fee is called Annual Registration Fee (ARF) and distinguishes between professional products and non-professional products. A higher fee is also due when "re-instating product on the register/late ARF", with the same distinction between professional and non-professional product.
For each of these annual fees, €25 needs to be transferred to the Poisons Information Centre to "cover the cost of maintaining the poisons database". There is also a fee to obtain a Certificate of Inclusion in the Register.No detail provided on the exact purpose of the fee.
IT / Simple flat annual fee for the registration of a single BP according to article 80 of the BPR. No detail provided on the exact purpose of the fee.
NL / Simple flat annual fee for the placing on the market of BPs. No detail provided on the exact purpose of the fee.
AT / Simple flat annual fee for the registration of a single BP and BP families per calendar year. No detail provided on the exact purpose of the fee.
SK / Different annual fees: for the inclusion of a BP in the register of BPs placed on the Slovak market, for a single BP placed on the market based on application for national authorisation or of Union authorisation where SK CA were the evaluating authority, for a single BP placed on the market based on application for mutual recognition in sequence or in parallel, for a BP placed on the market based on a specific regulation. No detail provided on the exact purpose of the fee.
NO / A basic annual fee applies to registered BP and BP families. Additionally, a variable annual fee applies based on the sales volume (reported to the National Product Register for the preceding year) and the hazardous properties of the BP (i.e. the classification and labelling of the BP).The details on the purpose of the annual fee are stated in paragraph 4 of the Norwegian biocide regulation implementing the BPR. The annual fee should cover the actual expenses of the services provided by the authorities (all expenses, including enforcement, which are not directly connected to the handling of application for product authorisation).
SE / The annual fee is based on the amount of BPs sold the year before, e.g 2013 is used as reference year for the 2014 annual fee. For 2015, the Swedish annual fee will correspond to 4% of the sales value in 2014 for each authorised BP with a corresponding minimum and maximum fee. The purpose of the fee is to finance enforcement and information to applying companies and to partly finance the national data base for biocidal products (the annual fee is applicable also for biocidal products that are authorised under the existing national practice during the transitional period).
UK / A "General Industry Charge" (GIC), which is charged under the Biocidal Products (Fees and Charges) Regulations 2013, applies industry-wide annually to cover the costs for on-going general activity carried out by UK CA in operating the biocides regulatory framework

2.3. Support measures for SMEs

Similarly to the annual fee, only 7MSs (BE, IE, IT, LU, AT, SE, DE) have planned measures to support their SMEs in this process; whilst 21 of the respondents had not.

Among such measures, 3 out of the 7MSs (BE, IT, LU) provide reduced rates (e.g.percentage of initial fee) for SMEs according to their respective size (micro, small, medium).3MSs (SE, AT, DE) have established special payment instalments for SMEs to split the different amounts in different phases[1].

This is summarised in the table below.

Member States / Existing measures supporting SMEs
BE / Reduced costs for evaluation of active substances (-40%) and authorisation procedure of BPs (-40%) except for modifications/prolongation/renewal under different procedures as well as for overhead expenses covering administrative costs.
IT / Fee reductions for evaluation and authorisation procedures: 60% of standard fee for micro companies, 40% for small, 20% for medium sized companies.
LU / Applicable reduction rates for evaluation and authorisation procedures : medium companies (20% of basic fee for evaluation of AS and 10% for BP authorisation), small (40% of basic fee for evaluation of AS and 20% for BP authorisation), micro (60% of basic fee for evaluation of AS and 30% for BP authorisation).
AT / Instalments for up to 5 years if the fees are above 50.000€.
SE / Provisions include a possibility of splitting payments into several instalments and phases, according to Chapter 9 Section 1 in the Ordinance (2013:63) on Fees for Pesticides.
DE / Splitting payments into several instalments is negotiable on a case-by-case basis.

3. comparative evaluation of the levels of fees payable to competent authorities

This section aims at emphasising the divergences of fee levels among the countries under study for the four regulatory procedures detailed in section 1.4. The tables below illustrate the different levels of fees payable in the MSs, EEA countries and Switzerland for the evaluation of AS, the authorisation of BPs, their mutual recognition, the potential adoption of an annual fee, and the potential establishment of measures for SMEs. The minimum and maximum fees established in some MSs correspond to the fee for procedures related to a single PT or a single BP.

3.1. Fee for AS approval – articles 4-11 of the BPR

One major comment is that the fee for the AS evaluation of one product type (PT) varies considerably from one MS to another, ranging from less than 150.000€ (BG, BE, GR, HR, IT, LV, LT, HU, SI, ES, CZ, FI, PT) to a range of 150.000-200.000€ (FR, LU, MT, DE, SK, DK). Lastly, in some MS, this fee is clearly above 200.000€ (IE, AT, NO, SE, UK, PL, NL[2]). However, approximately one third of the respondents (12 MS) did choose to set this fee below 150.000€.

The established fees for the evaluation of additional PTs (when this data was available) are in most MSs lower than the fee for the evaluation of a first PT (BE, CZ, DK, GR, IE, FR, HR, IT, LV, LU, HU, PL, SI, AT, NO, DE, FI), or equal to it (LT, SE, PT), except for LT (where the fee for one PT is multiplied according to the number of additional PTs). In 5MSs (BG, ES, SK, MT, UK), the amount of this fee was not specified.

3.2. Fee for BP authorisation – articles 29-31 of the BPR

As regards the fee for the authorisation of a BP, it appears that more than half of theMSs (17) have established the latter below 20.000€ (BE, BG, GR, IE, HR, IT, HU, PL, NL, SI, ES, SK, IS, CZ, UK, FI,PT), whilst 8 have set it above 20.000€ (DK, FR, LV, LT, LU, AT, NO, SE), among which 5 have set it above 40.000€ (LV, AT, NO, DE, SK).

The established fees for the authorisation of a BP family (when this data was available) are in most MSs higher than the fee for the authorisation of a single BP (BE, DK, GR, IE, HR, LV, LU, HU, NL, SI, AT, NO, SE, DE, IT, FI, FR) or equal to it (CZ, ES, PL). In 6MSs (BG, SK, IS, UK, LT, PT), the amount of this fee was not specified.


3.3. Fee for mutual recognition of BP authorisations –articles 32-40 of the BPR

In 10 MS, the fee to obtain a mutual recognition of a BP authorisation exceeds 5000€ (DK, FR, NL, AT, FI, NO, SE, DE, SK, UK), half of which MSs have set this fee above 10.000€ (DK, FR, SE, DE).

However, in 18MSs (BE, BG, CZ, EE, GR, IE, HR, IT, LV, LT, LU, HU, PL, MT, SI, ES, IS, PT), the mutual recognition fee for a single BP is situated below 5000€, as is the average for all respondents (approximately 4000€).

The established fees for the mutual recognition of a BP family (when this data was available) was in most MSs higher than the fee for the mutual recognition of a single BP (BE, DK, GR, HR, LU, HU, SI, AT, SK, NO, SE, DE, FR) or equal to it (EE, NL, ES, PL, FI). In 8MSs (BG, CZ, IE, LV, MT, IS, UK, LT), this fee was not specified.

3.4. Annual fee – article 80 of the BPR

See section 2.2.

Most MSs who have established an annual fee have chosen to set it below 500€ (BE, IE, IT, AT, NO, SK) at an average of 280 EUR (i.e. 1960 EUR for these 6 countries). NL stands out with a fee above 1000 EUR, at 1200 EUR along with Se whose annual fee varies between 300 and 30.000 EUR depending on the value of sales. UK also has a general industry charge, which was however difficult to estimate and is therefore not available.

Details are provided in the tablesin Annex 1.

4. final comments

On the basis of this study, bearing in mind the advantages of resorting to a Union authorisation which opens access to the entire Union market at once instead of having to undergo the more complex mutual recognition process, it appears that the costs ofresorting to national authorisations via mutual recognition of BPsis not significantly differentfrom those of applying for Union authorisation.

Regarding annual fees, similar conclusions can be drawn. However, in the case of annual fees, the issue identified through communication from stakeholdersis the concern that, for products authorised by the Union, companies might be forced to pay both the ECHA and MS' annual fees, which would create a serious disincentive of opting for a Union authorisation.

This bears considerable importance in the context of the COM review of Regulation 524/2012, notably with regard to the level of fees payable to the ECHA.

ANNEX 1: LEGISLATIVE FRAMEWORK, OVERALL STRUCTURE AND FEE LEVELS IN MS, EEA COUNTRIES, AND SWITZERLAND